Automation platforms in regenerative medicine: why, what, and when?

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Reproducible manufacture of cellular products at high quality and clinical grade is essential for the realization of novel cell therapies. This applies to stem cell–derived products in regenerative medicine as well as CAR-T cell products in immuno-oncology, or gene–engineered hematopoietic stem cell grafts.

The clinical manufacturing of such cell products is a complex process. It requires many handling steps, skilled operators who have undergone extensive training, a dedicated clean room infrastructure and stringently controlled processing steps. These complex requirements restrict manufacturing to a limited number of sites and products, and drive up the manufacturing costs.

Automation can help to standardize and simplify manufacturing processes by reducing costs, enabling reproducibility and scalability, and guaranteeing a safe and clinically effective cell product.

Moreover, Dr Andrew Kaiser will give you first-hand insights about process development on the CliniMACS Prodigy® Instrument (Miltenyi Biotec), a closed and automated platform for GMP-compliant cell manufacturing. It enables automation of a wide range of processing steps from cell culture, through cell separation and transduction, up to final product formulation, and can be used with various cell types, including ES and iPSC-derived cells, as well as mesenchymal and hematopoietic stem cells.

At Miltenyi Biotec, we’re committed to empowering scientific discovery and impacting human lives. For more than 25 years, our work has played an essential role in the biomedical research and cellular therapy community. Our innovative tools support research at every level, from basic research to translational research to clinical application. Used by scientists and clinicians worldwide, our integrated technologies cover sample preparation, cell separation, cell activation, transduction and electroporation, cell culture, cell analysis and cell sorting.